Tasigna (nilotinib) is used to treat Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML). It is a chemotherapy drug in a class of drugs called tyrosine kinase inhibitors (TKIs). CML is a type of blood cancer. TKIs help stop the cancer cells from growing. Novartis, maker of Tasigna, failed to warn doctors and patients in the U.S. of the risk of developing atherosclerosis and peripheral arterial disease (PAD) associated with Tasigna use.
Tasigna can cause serious and fatal side effects including:
- QT prolongation which can cause sudden death
- Low blood count
- Bleeding in the brain
- Decreased blood flow to the brain, heart, or leg
- Liver problems
- Tumor lysis syndrome (TLS)
- Kidney problems
Tasigna carries a Black Box warning for QT prolongation and sudden death, but not for atherosclerosis.
Tasigna and Atherosclerosis
Many studies, published in highly-respected medical journals, have found a link between Tasigna and atherosclerosis. The first study, published in 2011, found that 25% of Tasigna experienced vascular problems with 16% developing peripheral arterial disease. There were nine studies published in 2013, linking Tasigna to atherosclerosis, prompting Health Canada and Novartis to issue warning letters to doctors and consumers in Canada.
Even though one of those studies was a postmarket review by the U.S. Food and Drug Administration (FDA), no such warning letters were issued in the U.S.
Atherosclerosis, also referred to as “hardening of the arteries”, is a life-threatening condition. It can lead to serious diseases and potentially fatal health events. Consequences of atherosclerosis can include:
- Heart attack
- Embolic occlusion
- Peripheral artery disease
- Coronary heart disease
- Carotid artery disease
- Chronic kidney disease
- Gangrene and amputation due to poor circulation
Illegal Marketing and Kickbacks
In 2015 Tasigna maker Novartis agreed to pay $390 million to settle a U.S. Department of Justice (DOJ) lawsuit over illegal marketing practices including paying kickback to specialty pharmacies and others. The drug company was also making false claims that Tasigna was better than competing drugs. The DOJ said, “Novartis incentivized and pressured the pharmacies to emphasize benefits to patients while understating the drug’s serious, potentially life-threatening side effects.”
With over $1.7 billion in sales in 2016, Tasigna is one of the best-selling chemotherapy drugs worldwide.
If you have developed atherosclerosis as a result of taking Tasigna or lost a loved one to a fatal Tasigna side effect, you can learn more about your rights and how you can recover damages for your losses by speaking with an experienced defective drug lawyer.